Status:

RECRUITING

A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable ...

Eligibility Criteria

Inclusion Criteria:

  • Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening.
  • Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening:

Metformin, Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist.

  • Need of intensification with basal insulin, as indicated at the discretion of the investigator.
  • Recorded HbA1c value ≥7% within the last 90 days prior to randomization.

Exclusion Criteria:

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Previous participation in this study. Participation is defined as signed informed consent.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.
  • Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening.
  • Any disorder which in the investigator's opinion might jeopardize participant's safety.

Key Trial Info

Start Date :

August 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2028

Estimated Enrollment :

586 Patients enrolled

Trial Details

Trial ID

NCT07112339

Start Date

August 15 2025

End Date

August 31 2028

Last Update

April 6 2026

Active Locations (75)

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Page 1 of 19 (75 locations)

1

Centricity Research Calgary Endocrinology

Calgary, Alberta, Canada, T2H 2G4

2

Alta Clinical Research at Hermitage Medicentre

Edmonton, Alberta, Canada, T5A 4L8

3

Fraser Clinical Trials Inc.

New Westminster, British Columbia, Canada, V3L 3W4

4

Winnipeg Clinic

Winnipeg, Manitoba, Canada, R3C 0N2

A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes | DecenTrialz